NIPER Hyderabad had a star-studded Academia-Industry Synergy day on 23rd Aug, 2018. I was asked to moderate apanel on Innovation and Entrepreneurship. I chose to focus on the aspect of driving innovation already at NIPER-H towards commercialization. Invited Dr. Ashutosh of NIPER to identify where the gaps are, and put them to a panel of seasoned people drawn from industry in different areas of expertise spanning from technology transfer, chemistry, determining cell and animal model activity, development of pharmaceutical properties etc.

In the picture above, taken with the Director of NIPER, from left to right, my expert panellists were

Dr. Suman Kapur of BITS-Pilani Hyd, had to leave early but she shared her challenges and experience of developing point of care diagnostic devices.

Many useful suggestions came from not just the panel but also students and members of the audience. These will be compiled and used to continue the dialogue with NIPER-H to see how best to implement them.

Dr.Jugnu Jain

Co-Founder & CEO

Today, there is an increasing demand for high quality, personalized treatments for diverse pathologies including cardiovascular diseases, cancer, obesity and diabetes. The molecular research that underlies new treatment development is largely propelled by material and informational support provided by bio banks.However, putting bio banking on the map of the healthcare system calls for the proactive participation of medical institutions, community medical centers and policy makers. Though the sector is still growing, a handful of women entrepreneurs are leading this change from the front. Dr.Jugnu Jain, Co-Founder and CEO, Sapien Biosciences, is one such woman, who has been changing the landscape of bio banking in India, while breaking several stereotypes.

With 26 years of professional experience in the U.S. and UK, Dr.Jugnu decided to take the biggest risk of her life by quitting her job at Vertex Pharmaceuticals, a top biotech firm and establishing her own venture in India. She always had the desire to use her skills and experience for the welfare of the Indian population. Fortunately, Dr.Jugnu happened to reconnect with her former Vertex colleague Sreevatsa Natarajan, who was planning to start a biotechnology firm in Hyderabad. As their ideas resonated, they co-founded Sapien Biosciences – India’s first commercial bio bank in 2012, with a vision to be a premier global biotech firm that employs human translational platforms for the discovery and development of novel diagnostics, bio markers and drugs with better clinical outcomes.

“We started a totally new concept in India. My co-founder really helped get the venture off the ground; without him I would n’t have made such a big decision,” recalls Dr. Jugnu.“Even though I had wanted to create a world-class Indian bio bank and had several discussions with entrepreneurs at TiE – Boston, it was a huge leap of faith to return to India after 26 years abroad to start the company without anything in hand. Sreevatsa’s commitment to the project gave me confidence to take the leap.”

Overcoming the Hurdles

A post doctorate from Harvard University, UK, Dr.Jugnu’s major challenge was lack of funds during the initial phase of the entrepreneurial journey,as most of the funds and fund houses in India are actually private equity, rather than VCs, especially in life sciences. A majority of them prefer to make safe investments in companies, which have already shown proof of concept and generated revenues. The government has introduced various funds for new entrepreneurs in the life sciences sector, but there are many regulations that limit access to these funds. “We did not receive any government grants until last year when we won a GITA-DST award. We have also had to battle the perception that we should not be given grants, especially government funds, simply due to our partnership with Apollo Hospitals,” claims Dr.Jugnu. This stereotype is changing and she hopes collaborations and grants will be more accessible in the future.

“As an entrepreneur, you should be flexible and willing to work under sub optimal conditions, often with limited resources”

Her experience of working at Vertex enabled Dr.Jugnu to contact many potential clients, understand their work culture & requirements, and provide them the right solution. She has deep contacts & networks in the industry globally and connects with them regularly to gain advice & business leads. These contacts have enabled her to take Sapien Biosciences to international platforms and build partnerships globally.

Dr.Jugnu never learnt the habit of saying ‘No’to any work, which does increase her work load. Her father’s transferable job and her own education across many cities has helped make Dr.Jugnu a very adaptable person, who can handle change with a calm and positive attitude. She asserts,“As an entrepreneur,you should be flexible and willing to work under sub-optimal conditions,often with limited resources; these things are easier for me to handle as I have lived in different countries under different conditions”.

Her co-founder’s exit from the business last year left her with additional responsibilities. But, as we know, Dr. Jugnu is a strong woman and her dictionary does not have the word ‘impossible’ in it. She has simply worked harder along with her experienced management team and learnt the financial and compliance aspects from Sreevats a to shoulder the additional burden capably.

Dr.Jugnu does not believe in the term ‘woman entrepreneur’ and asserts that the playing field should be level for men and women and we should encourage risk-taking, irrespective of gender. She considers herself first and foremost a professional, taking pride in being a scientist, and then only a woman.“Only during my MSc, I was picked on and harassed as I was the only girl in my entire class.But everywhere else,in India, the UK and USA, I either had or was able to build multi-cultural environments that respected expertise and knowledge over and above gender, caste, nationality,etc,”says Dr.Jugnu. Moreover, her family always motivated and supported her during thick and thin. She strongly believes that there is no separate work and home life.“We have only one life. If things don’t go well in the home life, then that impacts our work life and vice versa. So it’s best if we can bring harmony between the two,” adds Dr.Jugnu. On this note, she tries to take short vacations now and then, to explore new places in India and abroad.

Staying Ahead

The need to stay abreast of the technological advancements in life sciences and the desire to enhance her understanding drive Dr.Jugnu towards reading technical journals, participating in conferences, writing blogs and forming networking forums in life sciences. Managing a one-of-a-kind business, hiring and training people, as well as establishing global partnerships, give her immense satisfaction and joy and add more meaning to her life. Two diagnostic tests have already been launched that help in optimizing treatment for cardiovascular and breast cancer patients she says, and more innovative diagnostics are in development at Sapien. For motivation, Dr.Jugnu advises new entrepreneurs to follow Vivekananda’s writings on work ethics,the biography of MarieCurie on singularity of purpose, and the Stanford commencement address given by Steve Jobs on setting goals for one’s life.

NIPER here held a Pharma Industry Summit on 24th March 2017, bringing together many govt, academic, industry and trade groups to speak about life sciences entrepreneurship in Hyd. It was a great initiative by Dr. Nanduri who himself brings many years of industrial experience to NIPER.

I particularly enjoyed the opportunity to moderate a panel discussion on “Start Up and Entrepreneurship in Life Sciences : Challenges and Way Forward”. Our panel consisted of two academics : Dr. Suman Kapoor of BITS Pilani Hyd who has brought out a device to determine TB infection much faster, and Dr. Madhusudhan of CCMB who is currently spearheading CCMB as an incubator for Life Sciences industry. Dr. Balaji Bhyravbhatla of Hylasco, a serial entrepreneur, Dr. Swaroop Vakkalanka of Incozen with several licensing deals under his belt, and myself as a co-founder of Sapien Biosciences represented LS Industry.

Each panelist spoke from their experience and shared some of their advice such as getting sufficient experience in one’s field before embarking on entrepreneurship, assessing your market often to manage risk, knowing your investor as well as your competitors, maintaining a diary of ideas and vetting them with experienced people, not being too possessive of one’s ideas, being willing to back out if timing is not right, forming teams of 3-4 people where 1 member is not a scientist etc.

There were many questions from the audience which made for a lively interaction.

Key action items that emerged from the panel were to

a) Form a LS group and hold a monthly networking meeting rotating at different forums several of which were offered immediately – CCMB, BITS campus, NIPER, Madhapur. A WA group will be created soon.

b) Create a comprehensive directory of LS companies in Hyd area

I noted that I knew all the panelists! This used to be common in LS meetings at TiE-Boston but it was nice that it finally happened in Hyderabad, a city I moved to 5 years ago.

Dr. Jain attended the Molecular Med Tricon 2017 conference at San Francisco 19-23rd Februrary, 2017. It was a blend of academia and industry working in the field of personalized medicine using molecular approaches. Dr. Jain joined Sapien’s partner, Trans-Hit Bio of Canada, who had put up a booth at the conference and promoted our partnership jointly.

Dr. Jain attended the Diagnostics and Cancer Tracks where dozens of companies and groups working on improving the sensitivity and specificity of blood- or urine-based markers ranging from cancer cells or cell-free DNA, RNA, proteins presented new technologies. Such groups are potential customers of our biobank so it was a good meeting from business point of view as well.

It is a pleasure to be working again with Dr. Anjana Rao, Jugnu’s postdoc advisor from Dana Farber Cancer Institute & Harvard Medical School days. Anjana is now the Chair of La Jolla Institute of Allergy and Immunology with a joint appointment at UCSD. Her lab’s work on Tet family of proteins and their regulation of transcription via methylation in cancer is well known (Rao et al Nat Immunol 2017).

Given our biobank’s deep collection of annotated cancer samples, both FFPE and matched live cells, it’s a synergistic alliance wherein Sapien brings not just samples but also its R&D expertise in histopathology, cellular and molecular biology to bear on the project. The project’s first milestone to standardize and automate LJI’s IHC protocol in Sapien hands has been reached.

Sapien Biosciences is a bio-repository that enables the development of cutting edge diagnostics and therapeutics for personalizing medicine. Patient samples and associated medical data that are systematically collated and ethically banked at Sapien are a necessary resource for rapid validation of novel diagnostic tests. Announcing the partnership with OncoStem Diagnostics Dr. Jugnu Jain, Co-Founder and CEO – Sapien Biosciences said, “We are very excited to be part of this launch of CanAssist–Breast which represents a paradigm shift in customizing Breast cancer treatment. Development of accurate recurrence diagnostics in cancer is particularly dependent on the availability of reliable retrospective information which is acutely lacking in India. To validate CanAssist-Breast, we mobilized five Apollo hospitals data archives to piece together complete 5 years treatment and outcome data for over 6500 Indian breast cancer patients”.

In India, about 1,50,000 patients are diagnosed of breast cancer every year and currently there are no affordable tests to predict the risk of cancer recurring. As a result, majority of early stage patients with low risk of recurrence are perhaps over-treated and thus bear toxic effects of chemotherapy treatment (CT) that reduces their ‘quality of life’. Additionally, studies have proven that the benefit of chemotherapy in such patients is known to be 10-15% suggesting many patients can be spared conventional CT. Highlighting the importance of CanAssist-Breast, Dr. Manjiri Bakre, Founder and CEO, OncoStem Diagnostics said, “CanAssist-Breast is our flagship product and is a boon for patients as well as doctors. It enables clinicians to assess the aggressiveness of the tumor and personalize and optimize therapy for their patients. The canAssist-Breast test can spare over 60,000 Breast Cancer patients in India and over 660,000 patients worldwide every year from the severe effects and unnecessary costs of chemotherapy-associated toxic”.

CanAssist-Breast test uses clinical parameters in combination with novel biomarkers quantified using a standardized technique which measures protein expression accurately. This information is integrated into a statistical algorithm to stratify patients as “low or high risk” for recurrence. “In India, due to a variety of reasons ranging from awareness to culture, Breast Cancer patients are diagnosed much later, with only 5-8% of patients being Stage 1 at detection. Consequently, the globally available recurrence prediction tests are not very impactful in geographies such as India and SE Asia due to their utility being limited to only Stage 1 patients and the prohibitive cost of the tests. CanAssist-Breast test can be used on a much wider pool of patients up to Stage 2B, and is priced at 1/6th the price of competitor tests and therefore aims to touch the lives of millions of patients worldwide”, added Dr Bakre.

CanAssist-Breast is being launched within the Apollo network in India and the worldwide launch is planned in a phased manner. Commenting on the partnership, Ms. Shobana Kamineni, Executive Vice Chairperson, Apollo Hospitals says, “Affordable and broad based tests to estimate the ‘risk of recurrence’ are an absolute necessity for ‘optimal and personalized’ treatment planning. Apollo has been at the forefront of recognizing personalized medicine as the future of healthcare delivery and has been adopting cutting-edge diagnostic tests to deliver better patient care to improve outcomes. Our association with Sapien is one of various initiatives we have undertaken with a vision to enable personalized medicine approach and we are very excited to see this crystallize through partnerships such as this one with OncoStem. Cancer recurrence space is largely unexplored, especially in India and needs immediate attention. I look forward to Apollo & Sapien pioneering the introduction & adoption of this important innovation from OncoStem across our network of oncology centres for the benefit of our patients.”

CanAssist-Breast is ISO-13485 accredited, and expects to acquire the CE mark by November 2016. These accreditations will enable the launch of the test in global markets later this year. The market for a breast cancer recurrence diagnostic space is currently valued at $ 3 Billion globally and is expected to grow at 18% CAGR. Clinical validation of CanAssist-Breast in India and the US demonstrates a high NPV (negative predictive value) of 95%, which is a measure of the accuracy of the test. The results of the global validation study are currently under review for publication.

About Apollo Hospitals Enterprise Ltd. (AHEL)

It was in 1983, that Dr. Prathap Reddy made a pioneering endeavor by launching India’s first corporate hospital – Apollo Hospital in Chennai. Now, as Asia largest and most trusted healthcare group, its presence includes over 8,600 beds across 50 Hospitals, 1,632 Pharmacies, 92 Primary Care and Diagnostic Clinics, 100 Telemedicine units across 10 countries. Health Insurance services, Global Projects Consultancy, 15 colleges of Nursing and Hospital Management, a Research Foundation with a focus on global Clinical Trials, epidemiological studies, genetic research and the upcoming first Proton Therapy Center across Asia, Africa and Australia.

In a rare honor, the Government of India issued a commemorative stamp in recognition of Apollo’s contribution, the first for a healthcare organization. Apollo Hospitals Chairman, Dr. Prathap C Reddy, was conferred with the prestigious Padma Vibhushan in 2010. For more than 30 years, the Apollo Hospitals Group has continuously excelled and maintained leadership in medical innovation, world-class clinical services and cutting-edge technology. Our hospitals are consistently ranked amongst the best hospitals globally for advanced medical services and research.

About Sapien Biosciences Pvt. Ltd.

Sapien Biosciences is a joint venture between Apollo Hospitals & Saarum Innovations that has created a world-class biobank and personalized medicine company that leverages Apollo’s leadership position in healthcare and Saarum’s cutting-edge life sciences research expertise for novel clinical and R&D applications. Sapien’s primary objective is to use its high-quality bio-repository that integrates ethically consented human samples with associated medical, pathological & treatment data and utilize this resource to develop & deliver high-end diagnostic applications. Further Sapien has entered into an alliance with Apollo Hospitals that allows Sapien to front-end Apollo’s personalized medicine initiatives. This allows Sapien to bring novel cutting-edge diagnostics to Apollo, either on its own or in collaboration with best-of-breed global institutions world-wide thereby enabling world-class healthcare to improve patient outcomes. Sapien has fully functional labs located within the Apollo Health City Campus in Hyderabad. For more information about Sapien Biosciences, visit www.sapienbio.com.

About OncoStem Diagnostics Pvt. Ltd.

OncoStem is a start-up diagnostic oncology company. It is founded by a Dr. Manjiri Bakre, a Cell Biology veteran with significant experience in US, Singapore and India in cancer biology and cancer drug discovery. It is funded by Artiman Ventures, an early-stage Silicon Valley-based venture fund that invests in white space companies that create or disrupt multi-billion dollar markets. OncoStem is primarily focused on developing novel tests which will predict ‘risk of cancer recurrence’ and thus enable physicians to prescribe targeted drugs to prevent cancer recurrence. OncoStem’s initial focus is breast cancer as it is the most common cancer in women across the globe but it also plans to develop similar tests for other cancers such as oral, glioma, lung and colon. For more information about OncoStem Diagnostics, visit www.oncostemdiagnostics.com

India has a high disease burden and a large number of patients. There is a tremendous need for Indian biobanks to preserve Indian samples, to capture the great diversity of diseases to spur research into earlier, more precise diagnosis and better treatments for diseases plaguing India. This review article summarizes the key components of building a systematic comprehensive biobank, type and formats of sample and data, and the ethical and regulatory guidelines in India. An example of a growing Indian biobank, Sapien Biosciences, is shared along with its business model to reach sustainability. This is done by developing clinical diagnostics internally using the annotated samples but also sharing samples and outcomes data with external investigators. Our goal is to highlight the immense untapped value of Indian biospecimens and data, to catalyze the formation of collaborative networks of biobanks both within and outside India

Lab-based training is available at Hyderabad, whilst data and project-based training is available at Ahmedabad, Bangalore, Bhubaneswar, Chennai, Delhi, Kolkata and other metro locations where Apollo Hospitals are present.

Appropriate ethical approval for projects involving handling of patient material or data is always taken. Students are trained in confidentiality and safety norms.

In addition to a certificate of internship and thesis, students are encouraged to present their findings in conferences. Longer-term interns that make significant contribution to projects may also be acknowledged in presentations and publications from our group. Mentoring of students aspiring for MS/PhD abroad is done on a case-by-case basis.

“Epidemiological and survival analysis of triple negative breast cancer cases in a retrospective multicentre study” comprising 257 TNBC cases collated from across five cancer centres in India has been accepted for publication. It should be out in a few months.

Next one summarizing data from >6500 Indian breast cancer cases, of all receptor types, is under preparation. Our goal is to exceed 10,000 cases within the year.

Our database of breast cancer samples, complete diagnosis and treatment info, combined with 3-5 year outcomes data offers tremendous opportunity to study Indian risk factors, identify optimal treatment paradigms for each subtype of patients, analyze cost-benefit ratio of different surgical/chemo/RT treatments, etc. We expect using them to also develop better prognostic, diagnostic and theranostic tests to improve survival in breast cancer patients.